Study title:
Phase IIa clinical trial for the evaluation of a vaccin against influenza virus H3N2
Date receipt dossier:
4 mei 2018
EudraCT number:
2017-004971-30
Company / Sponsor:
FluGen Inc.
Phase:
IIa
Treated organism:
Humans
Indication category:
Vaccination
Disease:
saesonal flu (H3N2)
Therapeutic approach:
Prevention
Genetic modification:
recombinant H3N2 influenza virus: 6 intern genes of the replication defective A/Puerto Rico/8/34 (PR8) strain with hemagglutinine and neuraminidase from A/Brismane/10/2007 (H3N2) strain
Method of transfer of nucleic acid of interest:
not applicable
Administered biological material:
recombinant replication defective H3N2 influenza vaccin (BRIS10 M2SR)
Route of administration:
Intranasal
Locations in Belgium:
SGS, Antwerpen
Nr of subjects:
24
Type of procedure:
Contained use only
Current status:
Authorized